Welcome to our dedicated page for Agios Pharmaceuticals news (Ticker: AGIO), a resource for investors and traders seeking the latest updates and insights on Agios Pharmaceuticals stock.
Agios Pharmaceuticals, Inc. (AGIO) is a biopharmaceutical company at the forefront of pioneering therapies for rare diseases, focusing on cellular metabolism and precision medicine. Based in Cambridge, Massachusetts, Agios is dedicated to discovering and developing breakthrough medications that target cancer, rare genetic metabolic disorders, and metabolic immuno-oncology. The company's core mission is to create transformative small-molecule medicines with a precision approach, enabling genetically or biomarker-defined patient populations to benefit from early proof-of-concept in clinical development.
Agios boasts a robust clinical pipeline, with significant advancements in its leading PK activator, mitapivat. Recent achievements include the Phase 3 ENERGIZE and ENERGIZE-T studies of mitapivat in thalassemia, demonstrating statistically significant results in reducing transfusion burdens in transfusion-dependent patients. The company is preparing for FDA submissions based on these promising outcomes, aiming to deliver the first oral treatment option for thalassemia patients.
Financially, Agios reported a net revenue of $8.2 million for the first quarter of 2024 from PYRUKYND® (mitapivat) sales, reflecting a 15% increase over the previous quarter. The company's strong cash position, with $714.3 million in cash, cash equivalents, and marketable securities as of March 31, 2024, ensures support for ongoing programs and potential pipeline expansion into 2026. Agios also anticipates a significant financial milestone with potential FDA approval of vorasidenib, expected to bring in $1.1 billion from upfront and milestone payments.
Agios' commitment to diversity and inclusion extends beyond its internal team to its clinical trials, aiming to build trust and support among diverse patient communities. The company’s strategic partnerships and collaborations further reinforce its mission to innovate and deliver life-changing therapies.
To stay updated on the latest developments and financial news about Agios Pharmaceuticals, visit their official website.
Agios Pharmaceuticals announced that its Phase 3 ACTIVATE trial of mitapivat for PK deficiency achieved its primary endpoint, with 40% of patients experiencing a significant hemoglobin increase of ≥1.5 g/dL, compared to none in the placebo group (p<0.0001). The safety profile aligns with prior data, and no adverse events led to discontinuation. Agios plans to seek regulatory approval in the U.S. and EU in 2021, with a potential launch in 2022. Topline results from the ACTIVATE-T trial are expected in Q1 2021.
Agios Pharmaceuticals (NASDAQ:AGIO) announced the launch of Anemia ID, a no-cost genetic testing program for patients with suspected hereditary anemias. This initiative aims to provide comprehensive diagnostic testing using a next-generation sequencing panel that explores over 50 genetic mutations linked to various anemia disorders. The program seeks to facilitate accurate diagnoses, thereby improving disease management and treatment options for patients. The testing is conducted by PerkinElmer Genomics, and all costs are covered by Agios.
Agios Pharmaceuticals (NASDAQ:AGIO) is set to present at the Piper Sandler 32nd Annual Virtual Healthcare Conference on December 2, 2020, at 2:00 p.m. ET. This event highlights Agios' commitment to advancing treatments in cancer and rare genetic diseases through its focus on cellular metabolism.
A live webcast will be available in the Investors section of the Agios website, with an archived replay accessible for two weeks post-presentation.
Agios Pharmaceuticals (NASDAQ: AGIO) announced that the FDA granted orphan drug designation to its PKR activator, mitapivat, for treating sickle cell disease. This designation highlights the significant unmet needs of this patient group. Mitapivat is an investigational oral drug aimed to enhance red blood cell energy and longevity by improving PKR enzyme activity. The company plans to initiate a Phase 3 study in 2021. Orphan drug designation provides benefits like market exclusivity upon approval, reduced FDA fees, and tax credits for clinical trials.
Agios Pharmaceuticals reported a net revenue of $31.7 million for TIBSOVO® in Q3 2020, a 15% increase from the previous quarter. Total revenue reached $34.7 million, up 33% year-over-year, supported by an 82% rise in TIBSOVO® sales. The company narrowed its 2020 revenue guidance for TIBSOVO® to $113–115 million. Upcoming milestones include topline data from the ACTIVATE trial by year-end and a supplemental new drug application for TIBSOVO® in Q1 2021. However, they withdrew the European Marketing Authorization Application for TIBSOVO® in AML following feedback from the EMA.
Agios Pharmaceuticals will host a virtual investor event on December 8, 2020, at 8:00 a.m. ET to discuss key clinical findings presented at the American Society of Hematology (ASH) Annual Meeting from December 5-8, 2020.
Eight abstracts from Agios and three from collaborators will be showcased, focusing on their oncology and rare genetic diseases programs. Notable presentations include findings on Ivosidenib and various studies related to Pyruvate Kinase Deficiency. For further details, the event will be webcast live on their website.
Agios Pharmaceuticals will host a webinar on November 19, 2020, from 8:00 a.m. to 10:30 a.m. ET, focusing on its pyruvate kinase-R (PKR) activation clinical programs and commercial outlook for hemolytic anemias. The event will feature presentations from Agios leadership and experts discussing PKR's role in treating disorders such as pyruvate kinase deficiency, thalassemia, and sickle cell disease. Attendees can access the live webcast through the Agios website, with a replay available for two weeks post-event.
Agios Pharmaceuticals (NASDAQ: AGIO) will hold a conference call on November 5, 2020, at 8:00 a.m. ET to discuss its third quarter 2020 financial results and business highlights. Interested parties can access the live webcast via the company's website or join by phone. Agios focuses on developing innovative treatments for cancer and rare genetic diseases, boasting two approved oncology medicines and a robust pipeline of investigational therapies.
Agios Pharmaceuticals has withdrawn its European Marketing Authorization Application for TIBSOVO® (ivosidenib) in treating adult patients with relapsed or refractory acute myeloid leukemia (AML) due to insufficient clinical data supporting its benefit-risk balance. The company is advancing two Phase 3 trials of TIBSOVO® in newly diagnosed AML, which could lead to future approvals in the U.S. and EU. The company emphasizes their commitment to developing targeted treatment options for AML patients.
Agios Pharmaceuticals (NASDAQ: AGIO) has announced the final overall survival (OS) analysis from its Phase 3 ClarIDHy trial assessing TIBSOVO® (ivosidenib) in previously treated patients with IDH1-mutant cholangiocarcinoma. While a trend indicating improved OS was noted, it lacked statistical significance. Nonetheless, a significant improvement in progression-free survival (PFS) was achieved (HR 0.37, p-value < 0.0001). The company plans to file a supplemental new drug application in Q1 2021 and aims for collaboration with regulators to advance treatment options for this aggressive cancer.
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